Dr Shrutin Ulman
Bengaluru
Summary
With over 25 years of global clinical development experience, I offer strategic leadership, regulatory acumen, and innovation in AI/ML-enabled medical solutions tailored for the Director, Clinical Research role. I have successfully led cross-functional teams in Asia-Pacific, Europe, and Africa, overseeing clinical trials, regulatory submissions, and strategic partnerships in ophthalmology and broader medtech domains. Notable achievements include developing an AI-based diagnostic tool for Retinopathy of Prematurity, leading wearable algorithm development for atrial fibrillation and respiratory monitoring, and co-developing a lung function device in line with pharma's Pill+ strategies. By establishing Centers of Excellence in Japan, South Korea, Australia, and Singapore, I have cultivated collaborations with hospitals, regulators, and key opinion leaders to integrate clinical needs with digital innovation for real-world patient impact in ophthalmology, respiratory, and cardiovascular care. My experience positions me to lead transformative clinical programs in the Asia-Pacific region.
Overview
28
28
years of professional experience
1
1
Certification
Work History
Research & Clinical Innovation Consultant
Philips
04.2023 - Current
- Manage and enable market access of solutions like sleep screening algorithms, cardiac rehabilitation and stress detection algorithms in APAC markets
- Established collaborations with pharma companies, medical device manufacturers, and regulatory agencies for cutting-edge clinical research.
- Managed multi-site clinical trials, overseeing protocol development, ethics submissions, and investigator training.
- Developed and implemented risk management strategies for hospital-based research and innovation programs.
- Initiated and oversaw clinical audits, identifying areas for improvement and implementing changes to elevate care standards.
- Enforced quality assurance programme requirements for routinely audited core measures for patients with pneumonia or advanced directives to maintain fallout rate.
Director of Clinical Research & Medical Devices
Philips
02.2020 - 03.2023
- Directed and executed clinical studies for medical device and SaMD development across key APAC markets, including India, Japan, South Korea, Singapore, Indonesia, and Australia, ensuring both real-world validation and successful regulatory approvals.
- Spearheaded research and validation of wearable technologies supporting remote patient monitoring, digital therapeutics, and AI-based diagnostics—spanning ophthalmology, cardiovascular, and respiratory domains.
- Managed cross-functional teams and collaborated closely with leading Key Opinion Leaders (KOLs) and partners in academic and tertiary hospitals across APAC to co-design clinical strategies, endpoints, and trials.
- Led strategic initiatives in clinical evidence generation, usability testing, and health economics to enable market access and alignment with global R&D objectives.
- Continuously tracked and evaluated program performance against clinical, regulatory, and commercial KPIs, and optimized strategies to meet timelines, compliance, and impact targets.
- Interpreted clinical and financial dashboards to drive informed decisions on cost efficiency, risk management, and return on clinical investment, supporting sustainable innovation and scalability in regional markets
- Improved clinical trial efficiency by streamlining processes and implementing new data management systems.
- Established performance metrics to evaluate team productivity and identify areas requiring improvement.
- Collaborated with legal, improved legal review of clinical operations and enhanced contract administrator function.
- Published results of groundbreaking clinical studies in prestigious journals, enhancing the organization''s reputation as a leader in medical research.
- Thought operationally and displayed communication and leadership skills to follow through on development plans.
Principal Scientist – Clinical Marketing and AI
Philips
09.2010 - 03.2020
- Led clinical validation studies for AI-enabled patient monitoring systems and diagnostic tools, overseeing all phases from study design to post-market evidence generation across Asia-Pacific, in the infant warmers and incubators, AI in high risk pregnancy detection and wearables for patient monitoring
- Spearheaded the development of an AI-based clinical decision support system for Retinopathy of Prematurity (ROP) using retinal image analytics—transforming neonatal vision care and demonstrating the successful intersection of clinical insight and AI innovation within the mother and child care portfolio.
- Directly contributed to clinical operations, including protocol development, data privacy assessments (GDPR/HIPAA), regulatory compliance, and submissions to ethics committees and health authorities, ensuring robust study design and ethical oversight.
- Drove hospital-based research in perioperative care, predictive analytics, and clinical decision support, and led collaborations with academic institutions to accelerate translational medicine initiatives.
- Managed investigator-initiated trials, aligning scientific inquiry with regulatory requirements and market needs.
- Led the creation and deployment of AR/VR-based simulation tools for anesthesiology and surgical training, enhancing clinical education through immersive technologies.
- Maintained strong working relationships with KOLs, ethics boards, regulatory bodies, and cross-functional commercial/medical affairs teams, enabling seamless alignment from concept to clinical implementation.
- Demonstrated outstanding product knowledge and clinical fluency, contributing to high customer satisfaction and impactful stakeholder engagement in a fast-paced, innovation-driven environment.
Director – Clinical Research & Trials
Trimedics Pvt Ltd
09.1999 - 09.2010
- Designed and executed clinical trials for pharmaceutical and medical device innovations.
- Led occupational health research projects, integrating biomedical engineering solutions into clinical practice.
- Developed electronic medical records (EMR) software to streamline hospital workflow efficiency.
- Pioneered the adoption of innovative technologies, streamlining operations and enhancing customer experience.
Application Specialist
Siemens
02.1997 - 08.1999
- Enhanced functionality of MRI and CT scanning applications.
- Developed meaningful alliances to achieve mutual objectives.
- Strengthened relationships with customers for improved satisfaction.
- Optimised application performance, resulting in a 20% increase in speed and reliability.
- Planned, researched and developed programme logic and code tests.
Education
Doctor of Philosophy - Electronics
Goa University
2005
Master of Business Administration - Marketing
Symbiosis Centre for Distance Learning
1998
Higher National Diploma - Occupational Health
Goa Medical College
1996
Master of Science - Biomedical Engineering
Indian Institute of Technology
1994
MBBS
Goa Medical College
1992
Skills
Key Skills & Expertise
- Clinical Trials & Regulatory Affairs: ICH-GCP, CDSCO, FDA, EMA compliance
- Pharmaceutical & Medical Device Research: Design, execution, and validation of clinical trials
- Medical Device Innovation: Wearables, AI-driven diagnostics, patient monitoring
- Translational Medicine & Digital Health: Integration of AI and real-world evidence in clinical workflows
- Strategic Leadership & Stakeholder Management: Multi-disciplinary team coordination in hospital settings
- Clinical Workflow Optimization: EMR integration, process mining, perioperative care improvement
- Leadership influence
- Risk assessment tools
- Regulatory compliance software knowledge
- Big Data analytics
- Continuous improvement
- Processes and procedures
- Attention to detail
- Team leadership & development
- Problem-solving
- Analytical thinking
- Team collaboration
Languages
English
Proficient
C2
Hindi
Intermediate
B1
Marathi
Upper Intermediate
B2
Certification
Licenses & Certifications
- Fitness and Return to Work, Harvard Medical School, CME
- ICH-GCP & Regulatory Compliance for Clinical Trials – University of London
- Perioperative Medicine in Action – University College London
- Process Mining in Healthcare – Eindhoven University of Technology
- Global Health and Disability – London School of Hygiene & Tropical Medicine
Hobbies and interests
- Writing
- Hiking and Trekking
Timeline
Research & Clinical Innovation Consultant
Philips
04.2023 - Current
Director of Clinical Research & Medical Devices
Philips
02.2020 - 03.2023
Principal Scientist – Clinical Marketing and AI
Philips
09.2010 - 03.2020
Director – Clinical Research & Trials
Trimedics Pvt Ltd
09.1999 - 09.2010
Application Specialist
Siemens
02.1997 - 08.1999
Master of Business Administration - Marketing
Symbiosis Centre for Distance Learning
Higher National Diploma - Occupational Health
Goa Medical College
MBBS
Goa Medical College
Doctor of Philosophy - Electronics
Goa University
Master of Science - Biomedical Engineering
Indian Institute of Technology